Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of near and intermediate visual outcomes with monofocal intraocular lenses: the mast study

Conditions: Patients Implanted With Monofocal Intraocular Lens

Summary: the purpose of this study is to evaluate the near and intermediate visual outcomes of patients who have undergone routine cataract surgery (removal of cloudy crystalline lens) with phacoemulsification (the break-up and removal of cloudy lens) and monofocal iol ( a plastic lens implanted to replace eye's natural lens) placement in the capsular bag in at least one eye.


Eligibility criteria:
inclusion criteria: * male or female patients at least 18 years of age * patients who underwent routine cataract surgery with phacoemulsification and monofocal iol placement in the capsular bag in at least one eye within the last 36 months * at least 1 month postop before follow-up evaluation * all patients must have a dcva of 20/25 or better

Keywords: previous cataract patients monofocal iol implant evaluation
wool clothing for the management of childhood atopic dermatitis (dessine2)

Conditions: Dermatitis, Atopic

Summary: the study is a sequentially recruited, cross-over-cohort, outpatient-based evaluation of the effectiveness of wool clothing, as compared to standard clothing, in reducing the severity of childhood atopic dermatitis (eczema) over two consecutive six-week periods.

the study will aim for a sample size of approximately 150 participants (equally distributed between 3 international sites) between the ages of 3 months and 5 years referred to the respective dermatology departments for management of moderate to severe atopic dermatitis. they will be sequentially recruited and randomized to the wool-to-standard clothing arm or standard clothing-to-wool arm. the study will run for 12 weeks for each participant with two consecutive 6-week periods for each intervention, either of wool followed by standard clothing or standard followed by wool clothing. participants will be assessed by a blinded trained researcher, at their initial appointment, 3 weeks, 6 weeks, 9 weeks and 12 weeks post commencement of the first intervention. the primary outcome is the severity of atopic dermatitis at 6 weeks post commencement of each intervention i.e.at week 6 and week 12. severity of atopic eczema will be measured using the eczema area and severity index (easi). secondary outcomes include the severity and change in the severity of eczema using the easi at 3 weeks, the validated investigators global assessment for atopic dermatitis (viga-ad™) score and quality of life assessment using the children's dermatology life quality index (cdlqi) at 3 and 6 weeks of each 6 week intervention period, as well as weekly patient oriented scoring atopic dermatitis index (po-scorad) scores.

Eligibility criteria:
inclusion criteria: * is aged between 3 months and 5 years of age at the time of recruitment * has moderate to severe eczema as determined by an easi score of 7 or above at their initial visit * has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf exclusion criteria: * has a known allergic contact dermatitis to wool or merino wool * is unable to attend all scheduled visits * has unstable eczema defined by an escalation of treatment requirements during the preceding 6 weeks. this would include flares of ad for any reason including infection, food allergy etc. * use of systemic corticosteroids within 6 weeks of study start. * any medical reason that is considered by the principal investigator to preclude enrolment.
exercise training in patients with chagasic heart disease without ventricular dysfunction

Conditions: Chagas Disease

Summary: the prevalence of chagas' disease continues high even in the developed countries. chagasic cardiomyopathy with preserved ventricular function is an understudied form of chagas disease. since a majority of patients with these changes progress to dilated form with ventricular dysfunction with all its serious consequences, it is interesting to better understand the pathophysiology of the disease at the stage where there electrocardiographic changes and preserved ventricular function. and besides, search strategies to slow the progress, or even prevent the chronic phase of the disease. for this reason the investigators will evaluate the effects of exercise training in patients with chagas cardiomyopathy without ventricular dysfunction.

chagasic cardiomyopathy with preserved ventricular function is an understudied form of chagas disease. since a majority of patients with these changes progress to dilated form with ventricular dysfunction with all its serious consequences, it is interesting to better understand the pathophysiology of the disease at the stage where there electrocardiographic changes and preserved ventricular function. and besides, search strategies to slow the progress, or even prevent the chronic phase of the disease. for this reason the investigators will evaluate the effects of exercise training in patients with chagas cardiomyopathy without ventricular dysfunction.

Eligibility criteria:
inclusion criteria: * chagas' disease patients, diagnosed with at least two positive serological reactions to chagas' disease, * ejection fraction ≥55% exclusion criteria: * participation in a regular exercise program in the last 3 months preceding the survey * use of oral anticoagulant * use of a pacemaker or implantable cardioverter * hemodynamic instability * myocardial revascularization infarction or unstable angina in the last 3 months of the start of the protocol * diabetes mellitus * hypertension * pulmonary disease * valvular lesions * atrial fibrillation * angina of effort

Keywords: chagas disease exercise baroreflex sensitivity
subacromial impingement syndrome approach using high intensity laser therapy

Conditions: Subacromial Impingement

Summary: the purpose of this study is to assess the effectiveness of high intensity laser therapy in the treatment of subacromial impingement syndrome.

shoulder pain has a high prevalence in our society, several studies estimate an annual prevalence between 5% and 47%. it is one of the main causes of musculoskeletal pain, particularly in third place, after the low back pain and neck pain. symptoms of pathologies of subacromial space impingement syndrome, where, regardless of origin, pain is the number one symptom for the patient, which emanates functional impairment and the impact on quality of life. because of the need to implement research to assess the effectiveness of high intensity laser therapy with new studies mayor methodological quality of obtaining conclusive results, and based on the scientific evidence supporting the low-power laser therapy as a useful tool in addressing the shoulder tendon pathology, we consider very interesting the realization of this research project.

Eligibility criteria:
inclusion criteria: * patients between 18 and 75 years old with diagnosis of subacromial impingement syndrome or any of the pathologies that compose it (tendinosis-tendinitis supraspinatus and rest of the rotator cuff, subacromial bursitis and tendinitis of the long head of the biceps). * visual analogue scale (vas) less than or equal to 7. * forward flexion at least of 100º exclusion criteria: * calcific tendinitis * complete rupture of the rotator cuff. * adhesive capsulitis. * clinical history of pathologies that without affecting the shoulder joint refer to painful shoulder symptoms (cervical root involvement, cervical surgery, cervical osteoarthritis and neurological pathologies) * fibromyalgia * be receiving physiotherapeutic treatment or have received it previously for this pathology one month before the start of treatment. * patients with alterations of thermal sensitivity. * derived from the absolute and relative contraindications of laser therapy: * photosensitive patients * neoplastic processes * hyperthyroidism * pregnancy * patients with a history of epileptic seizures
optimization of hip-exoskeleton weight attributes

Conditions: Healthy; Gait, Frontal

Summary: the investigators are examining how weight distribution affects the way people walk, in terms of joint kinematics, kinetics, and muscle activity. the investigators are measuring these quantities while people walk while wearing a weighted belt. the investigators distribute the weights and walk for specified periods. they hypothesize that greater weight will have a greater effect on walking.

the purpose of this study is to examine how the amount and distribution of weight on the pelvis affects how people walk. the investigators two factors, weight and placement. they are examining how these factors affect muscle activation, joint motions and foot forces. the investigators plan to recruit 40 healthy adult individuals. each of the 20 experimental conditions (3x3 factorial and one control condition with no weight) will be recorded immediately in a single session. the investigators hypothesize that weight amount, gait speed and weight distribution will all affect how people walk, which will lead towards optimized design of hip exoskeletons.

Eligibility criteria:
inclusion criteria: * willing to commit to the full experimental session exclusion criteria: * functionally relevant lower limb musculoskeletal injury * functionally relevant osteoarthritis and weight bearing restrictions * severe respiratory problems that restrict the wearer from using a metabolic rate apparatus * patients with cardiac issues may be included, but the cardiac issue will be noted in the health history questionnaire
a study of hg146 capsule in chinese subjects with relapsed and refractory multiple myeloma

Conditions: Multiple Myeloma; Relapsed and Refractory Multiple Myeloma

Summary: this study is designed to evaluate the tolerability and safety of hg146 capsule in patients with multiple myeloma.

this study is mainly designed to evaluate the tolerability and safety of hg146 capsule in patients with multiple myeloma. secondly, to get pharmacokinetic data and preliminary efficacy of hg146 capsule in human. this study adopts the traditional design of "3 + 3" dose escalation. the starting dose is 5 mg and subsequent dose group is respectively for 10, 15 and 20 mg. for each dosing group, subjects are administered orally hg146 every other day for two weeks, followed by one week of rest with 21-day as one treatment cycle. patients will be treated for 4 cycles or disease progression or unacceptable toxicities, whichever comes first.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma requiring systemic therapy (international myeloma working group \[imwg\]) and 2 cycles of treatment including proteasome inhibitors and/or immunomodulators. * serum m protein≥ 10.0g / l, or urine m protein ≥ 200mg / 24h. * not suitable for autologous bone marrow transplantation or refuse autologous bone marrow transplantation or relapse after autologous bone marrow transplantation. * eastern cooperative oncology group (ecog) performance status of 0 or 1 or 2. * expected survival of ≥3 months. * hemoglobin ≥ 80 g/l, platelet≥75×10\^9/l, absolute neutrophil count≧1.0×109/l (1000 cells/mm3), prothrombin time(pt) and activated partial thromboplastin time ≤ 2 x upper limit of normal (uln). * bilirubin in serum\<1.5\*uln (2.0mg/dl/20mg/l/34.2μmol/l); glutamic-pyruvic transaminase (alt) and/or aspartate aminotransferase (ast)≤3\*uln (upper limit of normal). * normal electrocardiogram, echocardiography and myocardial enzyme spectrumcalibration of blood calcium concentration≤uln. * men and women, non-pregnant women who did not consider giving birth during the trial or five years after the end of the trial. * the patient is able to swallow the capsule. * patients must provide written consent. exclusion criteria: * severe allergies to the study drug or any of its excipients. * the possibility of gene toxicity, mutagenesis and teratogenicity. * men and women who did not have sperm or egg cells stored in vitro before the trial and who planned to have children again within five years. * pregnant or lactating women. * perform autologous bone marrow transplantation 3 months before admission. * receive allogeneic bone marrow transplantation. * use hdac inhibitors before. * two weeks prior to admission, received radiotherapy or bone marrow suppressive chemotherapy or biological treatment. * patients with history of other malignant tumors, except the tumor is in remission and has not been treated for at least 5 years. * patients with dysphagia or oral absorption disorder. * the investigators determine the conditions not suitable for the study.

Keywords: hdac inhibitor dose escalation hg146
acupressure for reducing anxiety in patients undergoing chemotherapy

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial evaluates whether acupressure is helpful to reduce anxiety related to chemotherapy. anxiety is experienced by many patients with cancer. anxiety can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. some patients diagnosed with cancer express interest in non-medicinal ways to manage symptoms. acupressure is a noninvasive intervention that can be used for many different symptoms. acupressure is well tolerated with minimal reports of adverse reactions, making it a good choice for patients with cancer. this study may help researchers learn whether acupressure is useful for managing anxiety in patients undergoing chemotherapy.

primary objectives: i. evaluate the feasibility of a nurse- and patient-applied acupressure intervention for patients with anxiety associated with active cancer-directed therapy. ii. patient-reported changes in acute anxiety associated with both the nurse and self-led acupressure interventions will be ascertained. outline: patients undergo acupressure over 15-120 seconds at a time for up to 15 minutes. after completion of the session, patients may optionally receive an education session on using acupressure at home. after completion of study intervention, patients who opted to receive education about using acupressure at home are followed up at 1 week.

Eligibility criteria:
inclusion criteria: * be over 18 years of age * be actively undergoing chemotherapy in the mayo clinic chemotherapy unit * report anxiety as a 1 or higher, on a scale from 0 (no anxiety) to 4 (severe anxiety) * be willing to undergo a short acupressure session exclusion criteria: * does not meet the inclusion criteria
phase ii pilot study to compare the bioavailability of buffered, enteric-coated ursodiol with unmodified ursodiol for chronic cholestatic liver disease and cystic fibrosis-associated liver disease

Conditions: Cystic Fibrosis; Gastrointestinal Diseases; Cholestasis

Summary: objectives: i. compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. ii. compare the differences in pruritus, weight gain, and liver function for both treatments.

protocol outline: patients are sequentially treated with 2 formulations of ursodeoxycholic acid: unmodified ursodiol (actigall) and buffered, enteric-coated ursodiol (ursocarb). there is a 24-hour washout between each 4-week course of therapy.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- chronic cholestatic liver disease cystic fibrosis-associated liver disease --prior/concurrent therapy-- usual and customary diet maintained throughout study, e.g., medium-chain triglyceride oil --patient characteristics-- pulmonary: no serious respiratory deficiency no acute illness no inability to swallow no fertile women

Keywords: cardiovascular and respiratory diseases cholestasis cystic fibrosis gastrointestinal disorders genetic diseases and dysmorphic syndromes rare disease
a study of vantictumab (omp-18r5) in combination with nab-paclitaxel and gemcitabine in previously untreated stage iv pancreatic cancer

Conditions: Pancreatic Cancer; Stage IV Pancreatic Cancer

Summary: this is an open-label phase 1b dose-escalation study to assess the safety, tolerability, and pk of vantictumab when combined with nab-paclitaxel and gemcitabine.

once the maximum tolerated dose (mtd) or maximum administered dose (mad) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and pk of vantictumab combined with nab-paclitaxel and gemcitabine. up to approximately 34 patients may be enrolled into the study.

Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥18 years * histologically documented stage iv ductal adenocarcinoma of the pancreas * availability of tumor tissue, either archival ffpe or obtained at study entry through fresh biopsy * ecog performance status of 0 or 1 * adequate hematologic and end-organ function * evaluable or measurable disease per recist v1.1 * for women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception exclusion criteria: * prior therapy before day 1 of cycle 1 for the treatment of stage iv pancreatic cancer * prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas * known hypersensitivity to any component of study treatments * known brain metastases, uncontrolled seizure disorder, or active neurologic disease

Keywords: pancreatic cancer stage iv pancreatic cancer
impact of time to coronary angiography on survival for nstemi

Conditions: Non ST-elevation Myocardial Infarction

Summary: this study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with nstemi.

the use of an invasive strategy for the management of nstemi according to estimated risk of 6 month mortality is recommended by international guidelines. nstemi appropriate for coronary angiography (and percutaneous intervention) have better outcomes compare with nstemi who are medically managed. whilst the national and international guidelines recommend that the timing of (in-hospital) coronary angiography (\<24, 24-72, 72-96 and \<96 hours) is based upon estimated clinical risk (using the grace risk score) there is scientific and clinical uncertainty as to the incremental benefit that more urgent invasive treatments strategies have over and above that of delayed strategies. moreover, the investigators recent research has shown that in the uk, may nstemi (eligible) for coronary angiography fail to achieve care according to the recommended time thresholds, and this is associated with potentially avoidable premature death. this study aims to investigate the extent to which the time to angiography impacts on survival in patients hospitalised with nstemi. it will characterise patients according to their estimated risk of death, their time to angiography, and associated outcomes. the investigators anticipate that this observational study will provide level b evidence for the benefits of the timing of an invasive strategy according to the grace risk score. the investigators are aware that the nice guidelines for the management of acute chest pain are to be updated in 2016.

Eligibility criteria:
inclusion criteria: * the target population will be all patients aged 18 to 100 years recorded within minap from 2004 to 2013 who have been hospitalised with nstemi and received coronary angiography. exclusion criteria: * age below 18 or above 100 or age missing * diagnosis not nstemi * patients who did not receive coronary angiography - as this is the investigators explanatory variable
envafolimab with chemotherapy and simvastatin in advanced biliary tract cancer

Conditions: Biliary Tract Cancer; Advanced Cancer

Summary: brief summary the goal of this clinical trial is to test whether the combination of envafolimab (an immunotherapy drug), chemotherapy (gemcitabine + cisplatin), and simvastatin can help treat advanced biliary tract cancer (btc) that cannot be removed by surgery or has spread. the study will also evaluate the safety of this treatment combination. key questions does the combination treatment help shrink tumors or slow cancer growth better than standard options? what side effects do participants experience with this treatment? what will participants do? receive envafolimab (iv infusion) + gemcitabine/cisplatin (chemotherapy) + simvastatin (oral pill) every 3 weeks for up to 8 cycles (\~6 months). after 8 cycles, continue with envafolimab + simvastatin alone every 4 weeks until cancer worsens or side effects become too severe. undergo regular scans, blood tests, and clinic visits to monitor tumor response and safety.


Eligibility criteria:
inclusion criteria: * age : ≥18 years old. * diagnosis : histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer). * prior treatment :treatment-naïve for unresectable/metastatic disease at initial diagnosis, or disease recurrence ≥6 months after curative surgery or adjuvant therapy. * performance status : ecog ps 0 or 1. * measurable disease : at least one radiologically measurable lesion per recist 1.1 (tumor lesion ≥10 mm on ct scan, lymph node ≥15 mm in short axis). * organ function : no severe functional impairment of heart, lung, brain, or other vital organs. exclusion criteria: * disease type : ampulla of vater cancer. * autoimmune disease : active or previously documented autoimmune/inflammatory disorders. * allergy : hypersensitivity to any study drug (envafolimab, gemcitabine, cisplatin, or simvastatin). * liver function : decompensated liver dysfunction. * psychiatric history : severe psychiatric disorders. * recent trials : participation in other drug/device trials within 4 weeks prior to enrollment. * compliance : inability to adhere to protocol requirements or follow-up schedule. * investigator's discretion : any other condition deemed unsuitable for participation by the investigator.

Keywords: biliary tract cancer envafolimab simvastatin immunotherapy chemotherapy